Container for hypodermic needle



Sept. 22, 1964 Ci CASTELLl CONTAINER FOR HYPODERMIC NEEDLE Filed Aug.27, 1962 INVENTOR 67/4/9456 (257544 ATTORNEY United States Patent3,149,717 CONTAINER FOR HYPGDERMIC NEEDLE Chm'les Castelli, NewBrunswick, NJ, assignor to Johnson & .l'ohnson, a corporation of NewJersey Filed Aug. 27, 1962, Ser. No. 219,492 6 Claims. ((31. 20643) Thepresent invention relates to containers for hypodermic syringe needleunits of the type'which comprises a needle secured to a hub and which,in turn, is adapted to be fitted on one end of a hypodermic syringe.

Typically, the hubs of such units are adapted to be screwed, orotherwise turned, into grooves or other portions of the front end of thesyringe. The syringe normally is especially adapted to receive the unit.The con tainer may be divided into two main components, Le, a holder, orshell, having an open bore at one end for receiving and holding a needleunit, and a cap for closing the open end of the shell. The hub may beprovided with a portion of non-circular cross section adapted to slideaxially into a corresponding portion of non-circular cross section inthe shell, so that the shell may be used as a wrench to apply the hub toa syringe through the open end of the shell.

The present invention contemplates a needle container of this generaltype, wherein the cap comprises a closure.

portion adapted to fit tightly into, or plug, the open bore of the hubto provide a hermetic seal therewith so that the interior of thecontainer and its contents may be maintained sterile. The leading end ofthe closure portion extends well into the container bore and ismaintained sterile as long as the container remains closed with theclosure portion of the cap in position in the shell. Thus, when theclosure portion and the remainder of the cap is removed from the shell,the adjacent portions thereof which might come into contact with the hubor the inner end of the needle, if a double ended needle is employed,are sterile and therefore can not contaminate the hub or the needle bycontact therewith during removal of the cap from the container.

A further feature of this invention is the provision of mechanical meansfor locking the cap in position on the shell and providing atamper-proof device which indicates when the container is open. Lockingmeans is provided on the cap which is adapted to enter into engagementwith cooperating means on the shell as the cap is moved axially, withrespect to the-needle unit, into position to seal off the open end ofthe shell. A non-reversible cam action occurs between the locking meansand the cooperating portions of the shell as the cap is moved intoposition on the shell so that the cap may not be removed from the shellby reversing the movement of the cap with respect to the shell. Morespecifically, the cap has looking portions which are adapted to springinto locking engagement with portions of the shell when the cap is movedaxially into position on the shell, but which can not spring out ofengagement with the shell if an attempt is made to remove the capaxially from the shell. The locking portions of the cap are attached tothe cap by a plurality of thin frangible extensions which may be brokenby twisting the cap with respect to the shell. Once the extensions arebroken, the locking means are separated from the cap thereby allowingremoval of the cap from the shell and permitting access to the needleunit contained therein. Since the container can only'be opened bybreaking the extensions, a positive indication is provided when a givencontainer has been opened or tampered with.

To allow sterilization of the inside of the container and its contentswith a sterilizing gas or fluid such as ethylene oxide or steam, ahollow sterilizing passage is provided in the cap connecting the bore ofthe shell with the out- 3,149,717 Patented Sept. 22., 1964 sideatmosphere. Blocking means, preferably in the form offiuid-fiow-permitting filtering means, is provided in the passage forpreventing movement of bacteria into the container but permittingmovement of sterilizing fluid through the passage and into the bore.

Other and further advantages of the invention will be apparent from thefollowing description and claims taken together with the drawingswherein:

FIG. 1 is a view in elevation of a needle container according to oneembodiment of this invention;-

FIG. 2 is an enlarged view partly in section and partly in elevationtaken along the line 2-2 of FIG. 1;

FIG. 3 is a view similar to that of FIG. 2 showing the cap as itapproaches the shell prior to assembly of the cap and the shell;

FIG. 4 is an exploded view showing the various parts of the needlecontainer of the preceding figures, including the needle unit;

FIG. 5 is a top plan view of the needle container of the precedingfigures at the same enlargement as FIG. 2;

FIG. 6 is a bottom plan view of the needle container of the precedingfigures;

FIG. 7 is a sectional view taken along the line 7-7 of FIG. 2;

FIG. 8 is a view partly in section and partly in elevation and showingthe removal of the cap from the shell after the cap has been twisted, orrotated with respect to the shell, to break the locking ribs.

Referring to the drawings, there is shown a needle container accordingto one embodiment of this invention, which comprises an elongatedholder, or shell, 11 having an open bore 12 at one end, and a cap 13 forclosing the open end of the shell. The shell 11 has an elongated frontportion 14 defining a hollow chamber 15 for receiving the needle, orcannula, 1d of a hypodermic syringe needle unit; and a widened rearportion 17 defining the open bore 12 for receiving the hub end of theneedle unit. The needle hub normally comprises a base portion 15* havinga flange 21 for fitting with a hypodermic syringe, not shown, and afront portion 22 of noncircular, in this case hexagonal, cross-section.A corresponding portion 23 of hexagonal cross-section is provided at thetop of the hollow chamber 15 of smaller cross-section just where itjoins the larger bore 12 in the shell, as shown most clearly in FIG. 7.Thus, once the needle unit is inserted in the shell it may be removedaxially, or longitudinally, therefrom but can not be rotated withrespect thereto since the fit between the corresponding hexagonalportions of the hub and the shell prevents this.

The cap comprises a hollow closure portion 24 having a plugging section25 which is adapted to fit into the hollow bore 12 of the shell and forma hermetic seal therewith. The outside surface of the closure portion 24is substantially cylindrical but tapered slightly outwardly away fromthe center line of the container from the front to the rear of theclosur portion. The outside diameter of the front end 26 of the closureportion is slightly less than the inside diameter of the mouth 27 of thebore in the shell, whereas the diameter of the plugging section 25 ofthe closure portion, which is spaced from the end closure portion,itself, are maintained sealed off and sterile inside the container aslong as the cap remains in position on the shell.

As shown most clearly in FIGS. 2, 3, 4, and 6, a pair of thin frangibleextensions 29 spaced approximtaely 180 from one another about the axisof the container depend from the cap 13 toward the shell 11. Each of theextensions 29 is connected at one end to the cap 13 and is integraltherewith. The extensions 29 define detents 31 at their lower ends forengaging the shell and the shell 11 presents a radially extendingperipheral flange 32 which defines a set of four slots 33 spacedapproximately 90 from one another for cooperating with the detents 31for holding the cap in position on the shell. The flange 32 is connectedto, and integral with, the rear end 17 of the shell 11. The detents 31have an external inclined face 34 which terminates in locking means inthe form of a locking ridge 35 and the diametrical distance acrossopposite locking ridges 35 is substantially greater than diametricaldistance between the outside surfaces 35 of the correspondingcooperating slots in the flange. However, the diametrical distancebetween the front ends of opposite inclined surfaces 34 of the detents31 is less than the distance between the outside surfaces 36 of thecorresponding slots. Thus, when the two detents 3% are registered with acorresponding pair of slots 33 the cap 13 may be pressed into contactwith the shell 11 in such a way that the closure portion 24 fits intothe bore 12 of the shell and the inclined surfaces 34 of the detents 31provide a cam action with the outside surfaces as of the slots 33 whichdeflects the detents radially inwardly toward the center line of thecontainer to allow them to pass through the slots. The extensions 29 aresutficiently resilient to allow the detents to be deflected in thismanner and to cause them to spring back to their normal position whereinthe ends of the inclined surfaces hook under the peripheral flange 32 ofthe shell. Thus, once the cap 13 is in position on the shell 11, it cannot be removed therefrom without breaking something, since the detents31 prevent axial movement of the cap away from the shell as well asradial movement with respect thereto. However, if the extensions 29 arebroken the cap 13 is no longer mechanically connected to the shell 11and may be removed therefrom for access to the contents of thecontainer.

The extensions 29 are constructed in such a way that when the cap 13 istwisted, or rotated, with respect to the shell 11 the extensions willbreak when only a moderate force is used to twist the cap. The elongatedfront portion 14 of the shell has an outer surface which is square incross section, as shown most clearly in PEG. 6, to enable the shell tobe gripped easily when the cap is twisted with respect thereto. A seriesof flutes 3'7 is provided around the cap to facilitate gripping the capfor the same purpose. The result of twisting the cap 13 with respect tothe shell 11 is shown graphically in FIG. 8. t is clear from this figurethat the broken portions of the extensions 29 which remain attached tothe cap 13 and the absence of the detents 31 provide a positiveindication that the container either has been opened or tampered with,and thereby provide a tamper-proof feature which insures the sterilityof the contents of the container.

In the embodiment shown in the drawings, a pair of extensions 29 andcorresponding detents 311 spaced approximately 180 from one anotherabout the center line of the container are provided; and a set of four(4) slots 33 spaced approximately 90 from one another about the centerline of the container are located in the flange 32 of the shell forengaging the extensions. Obviously only two of the slots 33 spaced 180from one another surrounding the container when the closure portion 24of the cap is in position in the bore 12 of the shell. The hollowpassage comprises a broadened lower section 39 for receivin the baseportion 19 of the needle hub when the cap is in position on the shell; asmall diameter opening ll in the top surface of the cap; and anintermediate portion 42 of somewhat larger diameter than the opening 41connecting the opening 439. to the broadened section 39 of the passage.Fluid-fiow-permitting filtering means in the form of a flat cylindricalfilter 43 is positioned in the top of the intermediate portion 42 of thepassage in such in such a way that a fluid entering the container fromthe outside atmosphere through the opening 41 at the top of the cap mustpass through the filter. The filter 43 may comprise a disc of sterilecotton fibers, or the like, but in any case it is constructed so that itprevents the movement of bacteria from the outside atmosphere to theinterior of the container while permitting a sterilizing fluid, such asethylene oxide gas or steam, to pass there-through.

The various parts of the container of this invention may be formed fromany suitable material. Preferably, however, the cap 13 is formed from aplastic such as polystyrene which is sufilciently brittle to allow thefrangible extensions 29 to be broken easily when the cap is twisted withrespect to the shell 11 to open the container. The shell 11 preferablyis formed from a material such as polyethylene or polypropylene, whichis sufficiently tough to provide the desired mechanical protection, andsufficiently resilient and impermeable to allow the parts to fittogether and provide a hermetically sealed container which completelyshields its sterile contents from contamination. The thickness of theextensions 29, where they are to be broken for opening the container,must be chosen to suit the type of material of which they are made sothat they are neither too fragile nor too strong to accomplish theirdesired function.

Having now described the invention in specific detail and exemplifiedthe manner in which it may be carried into practice, it will be readilyapparent to those skilled in the art that innumerable variations,applications, modifications, and extensions of the basic principlesinvolved may be made without departing from its spirit or scope.

The invention claimed is:

1. A needle unit package comprising a shell holding a needle unittherein and having a normally open end defining a bore of circularcross-section for insertion of the needle unit in the shell and removalof the unit therefrom; and a cap clos ng the open end of the shell andproviding a hermetic seal therewith and a sterile enclosure for theneedle unit, said cap comprising a closure portion fitting tightly insaid here, a plurality of frangible extensions spaced circumferentiallyabout said closure portion and connected at one end to said closureportion, locking means formed at the opposite ends of said extensions,and cooperating means formed on said shell and engaging said lockingmeans axially for preventing axial movement of the cap away from theshell and engaging said locking means laterally for preventing rotativemovement of the cap with respect to the shell, said frangible extensionsbeing adapted to break when the closure portion of said cap is rotatedby hand with respect to said shell, thereby allowing the closure portionof the cap to be removed from the shell and at the same time indicatingthat the package has been opened, said closure portion comprising ahollow plugging section having a normal outer diameter slightly greaterthan a corresponding portion of said bore and being inserted 1 tightlyinto said corresponding bore portion to provide a hermetic seal betweenthe cap and the shell along a circular line spaced substantially fromthe inside end of said closure portion, the hollow plugging sectionbeing open at the bottom and the outer end of said needle unit beingpositioned within said plugging section when the cap is locked inposition on said shell, whereby the end and side surface portions ofsaid closure portion inside of said circular line are maintained sterileas long as the cap is in position on the shell and said sterile surfaceportions protect the needle unit from contamination on removal of thecap from the shell.

2. A needle unit package according to claim 1 wherein portions of saidlocking means are displaceable radially with respect to the shell toenter into engagement with said cooperating means, and correspondingsurfaces of said locking means and said cooperating means are shaped toprovide a nonreversible cam action for radially displacing said lockingmeans during assembly of the cap on the shell.

3. A needle unit package according to claim 2, wherein the locking meansare in the form of wedge-shaped detents and said cooperating meanscomprises radially extending flange portions defining openings forreceiving said detents.

4. A needle unit package according to claim 1, wherein the cap defines ahollow passage communicating with said bore and with the atmospheresurrounding the package when the closure portion is in position in thebore, and which further comprises blocking means associated with saidpassage for preventing the movement of bacteria but permitting themovement of sterilizing fluid through the passage and into said bore.

5. A needle container according to claim 4, wherein said blocking meanscomprises fiuid-fiow-permitting filtering means.

6. A needle unit package according to claim 1, wherein the shell definesa wrench portion of noncircular crosssection adapted to receive a needleunit having a corresponding noncircular cross section and the needleunit may be moved axially but not rotated with respect to the shell whenthe noncircular cross section of the needle unit is in position in thewrench portion of the shell, whereby the shell may be used as a Wrenchin applying the needle unit to a syringe after the cap is removed fromthe package.

References Cited in the file of this patent UNITED STATES PATENTS695,759 McNish Mar. 18, 1902 2,092,547 Allenbaugh Sept. 7, 19372,122,294 Regan June 28, 1938 2,162,712 Hamberger June 20, 19392,162,754 Schauer June 20, 1939 2,690,947 Roehrl Oct. 5, 1954 2,695,723Waterman Nov. 30, 1954 2,744,650 Woessner May 8, 1956 2,899,097 HaskinsAug. 11, 1959 2,929,510 Penn Mar. 22, 1960 2,953,243 Roehr Sept. 20,1960 3,021,942 Hamilton a, Feb. 20, 1962 3,025,989 Williams Mar. 20,1962 3,028,992 Bucher et a1 Apr. 10, 1962 3,071,800 Patriquin Jan. 8,1963 FOREIGN PATENTS 216,920 Austria Aug. 25, 1961 397,792 Great BritainAug. 31, 1933 1,008,136 France Feb. 13, 1952

1. A NEEDLE UNIT PACKAGE COMPRISING A SHELL HOLDING A NEEDLE UNITTHEREIN AND HAVING A NORMALLY OPEN END DEFINING A BORE OF CIRCULARCROSS-SECTION FOR INSERTION OF THE NEEDLE UNIT IN THE SHELL AND REMOVALOF THE UNIT THEREFROM; AND A CAP CLOSING THE OPEN END OF THE SHELL ANDPROVIDING A HERMETIC SEAL THEREWITH AND A STERILE ENCLOSURE FOR THENEEDLE UNIT, SAID CAP COMPRISING A CLOSURE PORTION FITTING TIGHTLY INSAID BORE, A PLURALITY OF FRANGIBLE EXTENSIONS SPACED CIRCUMFERENTIALLYABOUT SAID CLOSURE PORTION AND CONNECTED AT ONE END TO SAID CLOSUREPORTION, LOCKING MEANS FORMED AT THE OPPOSITE ENDS OF SAID EXTENSIONS,AND COOPERATING MEANS FORMED ON SAID SHELL AND ENGAGING SAID LOCKINGMEANS AXIALLY FOR PREVENTING AXIAL MOVEMENT OF THE CAP AWAY FROM THESHELL AND ENGAGING SAID LOCKING MEANS LATERALLY FOR PREVENTING ROTATIVEMOVEMENT OF THE CAP WITH RESPECT TO THE SHELL, SAID FRANGIBLE EXTENSIONSBEING ADAPTED TO BREAK WHEN THE CLOSURE PORTION OF SAID CAP IS ROTATEDBY HAND WITH RESPECT TO SAID SHELL, THEREBY ALLOWING THE CLOSURE PORTIONOF THE CAP TO BE REMOVED FROM THE SHELL AND AT THE SAME TIME INDICATINGTHAT THE PACKAGE HAS BEEN OPENED, SAID CLOSURE PORTION COMPRISING AHOLLOW PLUGGING SECTION HAVING A NORMAL OUTER DIAMETER SLIGHTLY GREATERTHAN A CORRESPONDING PORTION OF SAID BORE AND BEING INSERTED TIGHTLYINTO SAID CORRESPONDING BORE PORTION TO PROVIDE A HERMETIC SEAL BETWEENTHE CAP AND THE SHELL ALONG A CIRCULAR LINE SPACED SUBSTANTIALLY FROMTHE INSIDE END OF SAID CLOSURE PORTION, THE HOLLOW PLUGGING SECTIONBEING OPEN AT THE BOTTOM AND THE OUTER END OF SAID NEEDLE UNIT BEINGPOSITIONED WITHIN SAID PLUGGING SECTION WHEN THE CAP IS LOCKED INPOSITION ON SAID SHELL, WHEREBY THE END AND SIDE SURFACE PORTIONS OFSAID CLOSURE PORTION INSIDE OF SAID CIRCULAR LINE ARE MAINTAINED STERILEAS LONG AS THE CAP IS IN POSITION ON THE SHELL AND SAID STERILE SURFACEPORTIONS PROTECT THE NEEDLE UNIT FROM CONTAMINATION ON REMOVAL OF THECAP FROM THE SHELL.